Females must not become pregnant while taking HANZEMA and for at least one month after its discontinuation. HANZEMA can cause severe birth defects in infants born to women who become pregnant during treatment with HANZEMA in any amount, even for a short period of time. Potentially any exposed fetus can be affected. There are no accurate means of determining whether an exposed fetus has been affected (see WARNINGS AND PRECAUTIONS: Special populations, Women of child bearing potential). If pregnancy does occur during treatment with HANZEMA or within one month after its discontinuation, HANZEMA treatment must be immediately stopped and a physician and the patient should discuss the desirability of continuing the pregnancy. HANZEMA should only be prescribed by physicians knowledgeable in the use of systemic retinoids, who have full understanding of the risks of systemic retinoid therapy and the monitoring requirements (see INDICATIONS AND CLINICAL USE)
